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Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027) (SMART)

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ClinicalTrials.gov Identifier: NCT02155335
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : January 9, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Prefilled Syringe delivery of Golimumab Drug: Smartject Device delivery of Golimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : October 5, 2015
Actual Study Completion Date : October 5, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Arm Intervention/treatment
Experimental: Prefilled Syringe→Smartject™ Device
Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab).
Drug: Prefilled Syringe delivery of Golimumab
Golimumab 50 mg solution for subcutaneous injection using prefilled syringe

Experimental: Smartject™ Device→ Prefilled Syringe
Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
Drug: Smartject Device delivery of Golimumab
Golimumab 50 mg solution for subcutaneous injection using Smartject Device.




Primary Outcome Measures :
  1. Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) [ Time Frame: Day 0 (post last injection) ]
    Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.

  2. Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections) [ Time Frame: Day 14 (2 weeks post injections) ]
    Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anti-tumor necrosis factor (anti-TNF) naive participants with a diagnosis of moderate-to-severe ulcerative colitis.
  • Mayo clinic score >= 6, including endoscopic subscore >=2;
  • Previous conventional therapy for a period of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to, or has contraindications to these treatments;
  • Anti-TNF experienced participants with an established diagnosis of moderate-to-severe ulcerative colitis, either not responding or partially responding to treatment with Remicade (infliximab). The participant must also meet the following criteria prior to initiating first-line anti-TNF treatment: Mayo score ≥ 6, including an endoscopic subscore ≥ 2; and previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to or have medical contraindications for such therapies (should be documented);
  • Sexually active women of child-bearing potential must agree to use a medically accepted method of contraception while receiving study drug and for 6 months after the stop of study drug

Exclusion Criteria:

  • Has a history of prior self-injection for any reason;
  • Has concomitant use of other biologic agents;
  • Has active tuberculosis (TB) within 12 months prior to the first injection or has suspected latent TB as indicated by a positive tuberculin skin test.
  • Has an active clinical non-tuberculous mycobacterial infection or opportunistic infection within 6 months prior to the first injection;
  • Has had an active infection and/or serious infection within 6 months prior to the first study drug administration;
  • Has had a live viral or bacterial vaccination within 3 months prior to the first study injection or Bacillus Calmette-Guerin vaccination within 12 months prior to the first study drug injection;
  • Has evidence of heart failure of New York Heart Association class 3-4;
  • Has a history of demyelinating disease such as multiple sclerosis or optic neuritis;
  • Has a history of systemic lupus erythematosus;
  • Has a history of lymphoproliferative disease, or any unknown malignancy or history of malignancy within the prior 5 years, with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence;
  • Has had an active hepatitis B infection;
  • Has an allergy or sensitivity to golimumab or its excipients;
  • Is pregnant or breast feeding;
  • Is sensitive to latex.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155335


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02155335     History of Changes
Other Study ID Numbers: 8259-027
2014-000656-29 ( EudraCT Number )
First Posted: June 4, 2014    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: March 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs